The process of taking an invention or discovery to the marketplace. It involves working the idea into a business plan, consideration of protection options, and determining how to market and distribute the finished product.
An exclusive right conferred by the government on the creator of a work to bar others from reproducing, adapting, distributing to the public, performing in public, or publicly displaying said work. Copyright does not protect an abstract idea; it protects only the concrete expression of an idea. In order to obtain copyright protection, a work must have originality and some modicum of creativity.
intellectual property (IP) (close)
Creative ideas and expressions of the human mind that have commercial value and are entitled to the legal protection of a property right. The major legal mechanisms for protecting intellectual property are copyrights, patents, and trademarks. IP rights enable owners to select who may access and use their intellectual property and to protect it from unauthorized use.
A grant of permission to use an IP right within a defined time, context, market line, or territory. There are important distinctions between exclusive licenses and nonexclusive licenses. An exclusive license is “exclusive” as to a defined scope, that is, the license might not be the only license granted for a particular IP asset, as there might be many possible fields and scopes of use that can also be subject to exclusive licensing. In giving an exclusive license, the licensor promises that he or she will not grant other licenses of the same rights within the same scope or field covered by the exclusive license. The owner of IP rights may also grant any number of nonexclusive licenses covering rights within a defined scope. A patent license is a transfer of rights that does not amount to an assignment of the patent. A trademark or service mark can be validly licensed only if the licensor controls the nature and quality of the goods or services sold by the licensee under the licensed mark. Under copyright law, an exclusive licensee is the owner of a particular right of copyright, and he or she may sue for infringement of the licensed right. There is never more than a single copyright in a work regardless of the owner’s exclusive license of various rights to different persons.
patent (U.S.) (close)
A grant by the federal government to an inventor of the right to exclude others from making, using, or selling his or her invention. There are three kinds of patents in the United States: a standard utility patent on the functional aspects of products and processes; a design patent on the ornamental design of useful objects; and a plant patent on a new variety of a living plant. Patents do not protect ideas, only structures and methods that apply technological concepts. Each type of patent confers the right to exclude others from a precisely defined scope of technology, industrial design, or plant variety. In return for the right to exclude, an inventor must fully disclose the details of the invention to the public so that others can understand it and use it to further develop the technology. Once the patent expires, the public is entitled to make and use the invention and is entitled to a full and complete disclosure of how to do so.
prior art (close)
The existing body of technological information against which an invention is judged in order to determine whether it is novel and nonobvious and can thus be patented.
prior informed consent (close)
The consent given by a party with respect to an activity after being fully informed of all material facts relating to that activity. The Convention for Biological Diversity requires that access to genetic resources shall be subject to the prior informed consent of the country providing the resources.
traditional knowledge (close)
Tradition-based creations, innovations, literary, artistic or scientific works, performances and designs originating from or associated with a particular people or territory.
Your source for expert commentary on IP management issues.
Soejarto DD, C Gyllenhaal C, JA Tarzian Sorensen, HHS Fong, LT Xuan, LT Binh, NT Hiep, NV Hung, TQ Bich, BM Vu, BV South-avong, K Sydara, JM Pezzuto and MC Riley. 2007. Biodiversity and Benefit-Sharing: University of Illinois at Chicago. In Executive Guide to Intellectual Property Management in Health and Agricultural Innovation: A Handbook of Best Practices (eds. A Krat-tiger, RT Mahoney, L Nelsen, et al.). MIHR: Oxford, U.K., and PIPRA: Davis, U.S.A. Available online at www.ipHandbook.org.
Editors’ Note: An earlier version of this case study was presented at the MIHR conference Using Intellectual Property for Improved Health in Developing Countries: An Evidence-Based Approach to Good Practice, Bellagio, Italy, June 14–18, 2004.
© 2007, DD Soejart et al. Sharing the Art of IP Management: Photocopying and distribution through the Internet for noncommercial purposes is permitted and encouraged.
Biodiversity and Benefit-Sharing: University of Illinois at Chicago
Communities in developing countries have not always benefited from bioprospecting inside those countries; conventional methods of benefit sharing and capacity building may marginalize the knowledge and contributions of traditional communities and plant genetic resources.
This disparity in conventional IP (intellectual property) law is beginning to be recognized, and attempts are being made to incorporate and reward indigenous knowledge and plant genetic resources involved in bioprospecting activity. The University of Illinois at Chicago (UIC) initiated and maintains a project that promotes bioconservation, health, scientific and legal capacity, and wealth creation in developing countries, “Studies on Biodiversity of Vietnam and Laos,” an International Cooperative Biodiversity Groups (ICBG) project.
The project aims to undertake an inventory of seed plants in Cuc Phuong National Park in Vietnam and of medicinal plants in Laos, as well as to discover novel biologically active molecules from these plants as possible candidates for drug development in the treament of malaria, cancer, TB, and AIDS. The project also aims to improve the living standards of the communities involved, as well as promoting scientific development and technology transfer.
A formal memorandum of agreement (MOA) was entered in 1999 between UIC; the Academy of Science and Technology, Vietnam; Cu Phuong National Park, Vietnam; Traditional Medicine Research Centre (TMRC), Laos; and Glaxo-Wellcome Research and Development, U.K. The MOA was revised when Purdue University and Bristol-Myers Squibb later joined the partnership. The Fogarty International Centre of the U.S. National Institutes of Health provided the funding.
The MOA aimed to recognize and manage IP rights, to obtain prior informed consent to access genetic resources and indigenous knowledge, and to ensure benefit sharing that could arise from the collaborative effort.
Royalty sharing was originally assigned through a trust fund based at UIC. However, the model, which was based on the UIC office of technology management strategy for sharing funds, proved to be problematic. The trust-fund approach was discarded in favor of using contracts to safeguard and manage IP rights; these contracts specify that countries from which plants are discovered can use the monies derived from benefit-sharing to set up their own trust funds or other organizations. Some developing countries’ institutions do not use trust funds. In this case, based on a payment made to the project by Glaxo-Wellcome, Laos has created a trust fund and Vietnam is initiating a foundation.
One patent application has been filed on a bioactive compound. The project has resulted in a better understanding on the benefits and risks of bioprospecting among all the parties. Numerous new compounds have been described, conservation and educational capacity have been improved at the park, research capacity has also been upgraded at TMRC, and various benefits to local people have come about as a result of the project. The benefits have included scientific personnel exchange, education and collaboration, and new equipment.
In the ICBG project, if UIC labs make a discovery, UIC is required to obtain IP protection, determine ownership in accordance with applicable national law, and take responsibility for the management and licensing of inventions. Similar arrangements exist in the contract for discoveries made by industry partners that analyze project samples in their labs.
This plant-based pharmaceutical discovery project represented a novel approach to IP management for UIC. It resulted in modifications to UIC’s other contracts for international collaborations in discovering natural product drugs. Previously, if UIC discovered a compound, it would take the lead role in developing the intellectual property. The standard contract is now structured so that whatever country in a collaboration is capable of IP management can take the lead if they choose to do so.
Sustainability is a critical issue in bioprospecting. There is a need to look at whether a plant source is required for commercial production of a drug. Other considerations include how to deal with economic changes in communities that cultivate the plant, how to ensure replacement of food crop fields that are converted to drug plant production, and what should be the role of science and technology in, for example, developing new genotypes of the drug source plant.
When prospecting, there are opportunities for value-added discoveries if uses of plants are found that do not exist in traditional medicine. If a plant species is found useful as the object of bioprospecting, the plant’s economic value goes up, but this can expose the local plant population to over-harvesting. Participatory conservation becomes crucial in such circumstances.
Importantly, informed consent in both the collection and use of plant/genetic materials, as well as acquiring information on their uses, is integral to any successful bioprospecting collaboration. Prior art must also be defined before any agreement is made, in consultation with both scientific and traditional communities. As plant collection proceeds, appropriate prior informed consent and plant collecting permits are obtained from Ministry, province, and local-level governments to ensure that collection is legal and source country/indigenous group rights are honored.
The pharmaceutical industry is understandably cautious about traditional knowledge and biodiversity: the results to date are meager, there are problems with fulfilling demand, bioprospecting can become an emotive and complicated issue, and recreating a natural process through chemical means is not always obvious. At this time, universities and small companies that are well-schooled in the ethics of bio-prospecting and the methodology of natural product drug discovery are likely to serve as sources of lead compounds for drug development by industry.
IP Rights Decisions and IP Management
The ICBG MOA provides that UIC take the lead in IP management and bear the cost of it as well. Patent ownership follows U.S. patent law and the Patent Cooperation Treaty. No provision was made for assigning joint ownership to those who are party to the MOA unless they are legally recognized as inventors on discoveries. Reservation of rights for further academic use of products would be negotiated in licensing agreements. Expenses for managing the project intellectual property may be deducted from any revenue earned from licensing the intellectual property. Equal shares of net revenue are allocated to a fund for the use of the plant source country and to a common fund for inventors, the technology management office, and collaborating institutions. A chapter by Soejarto and colleagues1 describes further distributions of net license income. The UIC researchers have joint authorship status on scientific papers with developing country scientists, collectors, and indigenous informants who have made appropriate scientific contributions. The technology transfer office generally does not manage copyright and data ownership rights. The sense of collaboration and mutual benefit is an imperative for the researchers, who see the success of their research program as generating mutual respect, consideration, and sharing based on fundamental ethical principles.
The original intent of the university-based trust fund model of benefit-sharing was to bridge the knowledge gap between the developed U.S. research enterprise for handling innovation, and the traditional-knowledge based systems of biodiverse regions such as Vietnam and Laos. The rationale for using this vehicle was to build an international forum for openly sharing knowledge of IP assessment, value, protection, and strategic management, as well as for funding of development projects in participating developing countries. However, the model took on connotations of imperialism, as a U.S. entity (UIC) was originally proposed to run it. The label trust fund seemed to trigger this, along with UIC lead management. Therefore, UIC later focused on the new contract model and abandoned the university-based trust fund. Vietnam and Laos have created trust funds or foundations in which to deposit income that may be generated under the MOA or resulting technology commercialization. Goals of these organizations are to support biodiversity conservation, health, and economic development. By-laws and operational methods have been developed based on models set out by international conservation organizations. The Laos trust fund now makes grants to small communities, and is searching for further funding sources.
The first patent application based on the project was filed in 2007. The development of the model, has had a substantial impact on UIC’s other natural product bioprospecting projects: a new template agreement for such projects, completed in 2003, features enhanced revenue sharing for developing country research partners.
External Factors That Affected Decision Making
A number of considerations influenced the strategies and decision making of UIC and its partners. These include:
Key Lessons Learned and Health-Access Issues
The following items represent key lessons from UIC’s biodiversity project, which may be applicable to other companies that aim to utilize traditional knowledge and biological resources:
All referenced Web sites were last accessed between 1 and 10 October 2007.
1 Soejarto DD, C Gyllenhaal C, JA Tarzian Sorensen, HHS Fong, LT Xuan, LT Binh, NT Hiep, NV Hung, TQ Bich, BM Vu, BV Southavong, K Sydara, JM Pezzuto and MC Riley. 2007. Bioprospecting Arrangements: Cooperation Between the North and the South. In Intellectual Property Management in Health and Agricultural Innovation: A Handbook of Best Practices(eds. A Krattiger, RT Mahoney, L Nelsen, et al.). MIHR: Oxford, U.K., and PIPRA: Davis, U.S.A. Available online at www.ipHandbook.org.